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OpenTrials
Completed

NCT Number: NCT01057680

Effectiveness of Creatine Supplementation and Exercise on Muscle and Bone

As we age, we experience a reduction in muscle and bone which inevitably decreases strength and the ability to perform tasks of daily living such as gardening, carrying groceries, and climbing stairs. Health costs associated with aging muscle and bone loss are in the billions of dollars. With the projected increase in life expectancy, the incidence of muscle and bone loss will rise and further drain the healthcare system, with greater need for hospitalization, treatment, and rehabilitation. Without effective strategies to counteract aging muscle and bone loss, we may face a healthcare crisis in the future. Creatine, a compound found in red meat and seafood, increases creatine phosphate stores in muscle, providing increased energy during high-intensity exercise. Short-term (i.e. 3-4 months) resistance-exercise and supplementation with creatine, have been shown to have a favorable effect on properties of aging muscle and bone. However, the longer-term (i.e. 1 year) effects of these interventions are unknown. Therefore, the purpose of this innovative research is to determine the longer-term effects of resistance-exercise and creatine supplementation (0.1g•kg-1) in older adults. The primary dependent variables to be assessed will include muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood indicators of liver and kidney function. This innovative, multidisciplinary research will help contribute to the successful pursuit of prolonged independent living by improving aging musculoskeletal health for older Saskatchewan adults. Saskatchewan provides a relevant setting for this research, given the higher percentage of older adults (15%), compared to the national average (12%).

We hypothesize that creatine supplementation will increase muscle mass, strength, and bone mineral density more than placebo.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Kinesiology and Health Sciences, Regina, Saskatchewan, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • greater than or equal to 50 years of age
  • males or postmenopausal females
  • not currently participating in resistance training

Exclusion criteria

  • pre-existing kidney abnormalities
  • previous fragility fractures
  • history of taking medications that affect bone mineral density in the past year including bisphosphonates, parathyroid hormone, calcitonin, hormone replacement therapy, or corticosteroids (i.e. within the past year)
  • suffer from severe osteoarthritis
  • have taken creatine supplementation within the past 6 months

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

Powder, 0.1 g per day, 12 months

Other names: Rivalus

sugar placebo

Dietary Supplement

powder, 0.1 g/day, 12 months

Primary outcomes

  1. Lumbar spine bone mineral density

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Proximal femur bone mineral density

    Time frame: Baseline and 12 months

  2. Whole body bone mineral density

    Time frame: baseline and 12 months

  3. lean tissue mass

    Time frame: baseline and 12 months

  4. Muscular strength

    Time frame: baseline and 12 months

  5. Muscle thickness

    Time frame: baseline and 12 months

  6. Bone speed of sound

    Time frame: Baseline and 12 months

  7. bone geometry

    Time frame: baseline and 12 months

  8. Complete blood count

    Time frame: baseline, 4 months, 8 months, 12 months

  9. Liver enzymes

    Time frame: baseline, 4 months, 8 months, 12 months

  10. kidney function (creatinine clearance)

    Time frame: baseline, 4 months, 8 months, 12 months

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Potential of Resistance-Exercise and Creatine Supplementation on Aging Musculoskeletal Health

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2010
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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